BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINAC

    MDR report key: 1070657 · Received July 2, 2008

    Report

    Report Number
    2916710-2008-00030
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 13, 2008
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K904364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS EVALUATED. THOUGH STILL UNDER INVESTIGATION, VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE, AS THIS MALFUNCTION, SHOULD IT RECUR, COULD POTENTIALLY CAUSE A SERIOUS INJURY. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "THE UNIT WAS SHOWING A HIGH SPEED GANTRY FAULT FIRST THING IN THE MORNING. AFTER MORNING CHECKOUT, THE SPEED WAS NORMAL. WE HAD THE UNIT FOR A PM DAY AND TARGETED THE AEROTECH PM MODULE AS THE POSSIBLE SOURCE OF THE PROBLEM. IT THEN TURNED INTO A HARD FAILURE WHERE THE GANTRY WOULD RUN AT APPROXIMATELY 3 TIMES NORMAL SPEED (11 SEC FOR 90 TO 270). THE SAFETY CONCERN WE HAVE IS THERE IS NO INDICATION THAT THE TACH FEEDBACK HAS FAILED UNTIL ROTATION IS ATTEMPTED. THE GANTRY GOES TO FULL SPEED WITH A SMALL DEFLECTION OF THE CONTROL THUMBWHEEL. THE POTENTIAL FOR A HORRENDOUS COLLISION IS POSSIBLE WHEN A PATIENT IS IN CLOSE PROXIMITY TO THE GANTRY. THIS IS COMPOUNDED ON AN OBI EQUIPPED MACHINE BECAUSE OF THE NEW POSITIVE DIRECT DRIVE. THE ONLY MOTOR LIMIT WOULD BE THE MAX CURRENT SETTING ON THE CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC ACCELERATOR, LINEAR, MEDICAL IYE VARIAN MEDICAL SYSTEMS CL-21EX

    Patients

    Seq Age Sex Outcome Treatment
    1